Viewing Study NCT01572792

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Ignite Creation Date: 2025-12-24 @ 3:54 PM
Ignite Modification Date: 2026-02-22 @ 12:23 PM
Study NCT ID: NCT01572792
Status: COMPLETED
Last Update Posted: 2017-04-21
First Post: 2012-04-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542859', 'term': 'aclidinium bromide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Study Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'Publication of the results by the Principal Investigator (PI) will be subject to mutual agreement between the PI and the sponsor', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The objective of this extension study was to assess long-term safety and tolerability. Thus efficacy assessments were considered only supportive to the lead-in study (LAC-MD-31), and were not categorized as primary, secondary, or additional'}}, 'adverseEventsModule': {'timeFrame': 'Follow-up call 14±3 days after end of treatment (Week 28±5 days)', 'description': 'The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation', 'otherNumAtRisk': 146, 'otherNumAffected': 37, 'seriousNumAtRisk': 146, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation', 'otherNumAtRisk': 182, 'otherNumAffected': 59, 'seriousNumAtRisk': 182, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation', 'otherNumAtRisk': 204, 'otherNumAffected': 64, 'seriousNumAtRisk': 204, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation', 'otherNumAtRisk': 194, 'otherNumAffected': 67, 'seriousNumAtRisk': 194, 'seriousNumAffected': 15}, {'id': 'EG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation', 'otherNumAtRisk': 192, 'otherNumAffected': 62, 'seriousNumAtRisk': 192, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Hip fracture', 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'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 194, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients to Experience Any Treatment-emergent Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formmoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 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patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formmoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '41.2', 'groupId': 'OG001'}, {'value': '35.3', 'groupId': 'OG002'}, {'value': '32.5', 'groupId': 'OG003'}, {'value': '38.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline of lead-in study to end of treatment (up to Week 52)', 'description': 'Potentially clinically significant change:\n\n\\>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid \\<0.85 x lower limit of normal (LLN) or \\> 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH \\<0.95 x LLN or \\>1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity \\>1.1 × ULN\n\nThe last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formmoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'title': 'QT interval change from baseline >30 msec', 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '55.9', 'groupId': 'OG002'}, {'value': '60.4', 'groupId': 'OG003'}, {'value': '48.4', 'groupId': 'OG004'}]}]}, {'title': 'QT interval >480 msec', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '2.6', 'groupId': 'OG003'}, {'value': '4.7', 'groupId': 'OG004'}]}]}, {'title': 'QTcB change from baseline >30 msec', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}, {'value': '39.7', 'groupId': 'OG002'}, {'value': '35.6', 'groupId': 'OG003'}, {'value': '38.4', 'groupId': 'OG004'}]}]}, {'title': 'QTcB >480 msec', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '5.7', 'groupId': 'OG003'}, {'value': '8.4', 'groupId': 'OG004'}]}]}, {'title': 'QTcF change from baseline >30 msec', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}, {'value': '27.8', 'groupId': 'OG003'}, {'value': '30.2', 'groupId': 'OG004'}]}]}, {'title': 'QTcF >480 msec', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '0.5', 'groupId': 'OG003'}, {'value': '2.6', 'groupId': 'OG004'}]}]}, {'title': 'QRS interval ≥100 msec & ≥25% increase', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}, {'value': '2.6', 'groupId': 'OG003'}, {'value': '4.7', 'groupId': 'OG004'}]}]}, {'title': 'PR interval ≥200 msec & ≥25% increase', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '3.1', 'groupId': 'OG003'}, {'value': '1.6', 'groupId': 'OG004'}]}]}, {'title': 'Heart rate ≥110 bpm & ≥15% increase from baseline', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}, {'value': '2.1', 'groupId': 'OG004'}]}]}, {'title': 'Heart rate ≤50 bpm & ≥15% decrease from baseline', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '7.2', 'groupId': 'OG003'}, {'value': '4.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline of lead-in study to end of treatment (up to Week 52)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}, {'value': '332', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.086', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.198', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.166', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '0.112', 'spread': '0.015', 'groupId': 'OG003'}, {'value': '0.109', 'spread': '0.015', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}, {'value': '332', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.101', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.038', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.005', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '0.030', 'spread': '0.015', 'groupId': 'OG003'}, {'value': '0.004', 'spread': '0.015', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Transition Dyspnea Index (TDI) Focal Score at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}, {'value': '332', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.731', 'spread': '0.277', 'groupId': 'OG000'}, {'value': '1.812', 'spread': '0.251', 'groupId': 'OG001'}, {'value': '1.742', 'spread': '0.235', 'groupId': 'OG002'}, {'value': '1.596', 'spread': '0.241', 'groupId': 'OG003'}, {'value': '1.324', 'spread': '0.246', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment', 'description': 'The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}, {'value': '332', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.862', 'spread': '0.945', 'groupId': 'OG000'}, {'value': '-3.646', 'spread': '0.861', 'groupId': 'OG001'}, {'value': '-5.527', 'spread': '0.819', 'groupId': 'OG002'}, {'value': '-4.306', 'spread': '0.847', 'groupId': 'OG003'}, {'value': '-4.059', 'spread': '0.853', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment', 'description': "St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'OG001', 'title': 'Aclidinium/Formmoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'OG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'OG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '18.6', 'groupId': 'OG002'}, {'value': '22.2', 'groupId': 'OG003'}, {'value': '24.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline of lead-in study to end of treatment (up to Week 52)', 'description': 'Potentially clinically significant change:\n\nSystolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline Pulse rate ≥110 bpm and increase ≥15% from baseline or ≤50 bpm and decrease ≥15% from baseline Weight increase or decrease ≥7% from baseline\n\nThe last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'FG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'FG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'FG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'FG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}], 'periods': [{'title': 'Lead-in Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '338'}, {'groupId': 'FG002', 'numSubjects': '338'}, {'groupId': 'FG003', 'numSubjects': '340'}, {'groupId': 'FG004', 'numSubjects': '339'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '272'}, {'groupId': 'FG002', 'numSubjects': '276'}, {'groupId': 'FG003', 'numSubjects': '268'}, {'groupId': 'FG004', 'numSubjects': '270'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '69'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '21'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'Site termination/COPD exacerbation/other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '205'}, {'groupId': 'FG003', 'numSubjects': '194'}, {'groupId': 'FG004', 'numSubjects': '192'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '179'}, {'groupId': 'FG003', 'numSubjects': '165'}, {'groupId': 'FG004', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Site termination/COPD exacerbation/other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'This study was conducted at 169 study centers, 160 in the United States, and 9 in Canada. The first patient was screened in April 2012 and the last patient visit was in June 2013', 'preAssignmentDetails': 'This was a double-blind, placebo- and active-controlled, 28-week treatment, extension study of the lead-in study, Study LAC-MD-31\n\nThose patients who chose to continue the treatment in the extension study and met the eligibility for the extension study remained on the same treatment as they were randomized to in the lead-in study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}, {'value': '192', 'groupId': 'BG004'}, {'value': '918', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo administered BID by inhalation'}, {'id': 'BG001', 'title': 'Aclidinium/Formoterol 400/12 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'BG002', 'title': 'Aclidinium/Formoterol 400/6 μg', 'description': 'Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation'}, {'id': 'BG003', 'title': 'Aclidinium 400 μg', 'description': 'Aclidinium bromide 400 μg administered BID by inhalation'}, {'id': 'BG004', 'title': 'Formoterol 12 μg', 'description': 'Formoterol fumurate 12 μg administered BID by inhalation'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '8.3', 'groupId': 'BG003'}, {'value': '62.8', 'spread': '8.7', 'groupId': 'BG004'}, {'value': '63.2', 'spread': '8.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '435', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '483', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 921}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2015-02-27', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2012-04-04', 'dispFirstSubmitQcDate': '2015-02-27', 'resultsFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2012-04-04', 'dispFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-09', 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment'}, {'measure': 'Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment'}, {'measure': 'Transition Dyspnea Index (TDI) Focal Score at End of Study', 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment', 'description': 'The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.'}, {'measure': "Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score", 'timeFrame': 'Baseline of lead-in study to Week 52 of treatment', 'description': "St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status)."}], 'primaryOutcomes': [{'measure': 'Percentage of Patients to Experience Any Treatment-emergent Adverse Event', 'timeFrame': 'Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)', 'description': 'For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis', 'timeFrame': 'Baseline of lead-in study to end of treatment (up to Week 52)', 'description': 'Potentially clinically significant change:\n\n\\>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid \\<0.85 x lower limit of normal (LLN) or \\> 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH \\<0.95 x LLN or \\>1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity \\>1.1 × ULN\n\nThe last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study'}, {'measure': 'Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value', 'timeFrame': 'Baseline of lead-in study to end of treatment (up to Week 52)'}, {'measure': 'Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)', 'timeFrame': 'Baseline of lead-in study to end of treatment (up to Week 52)', 'description': 'Potentially clinically significant change:\n\nSystolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline Pulse rate ≥110 bpm and increase ≥15% from baseline or ≤50 bpm and decrease ≥15% from baseline Weight increase or decrease ≥7% from baseline\n\nThe last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Chronic Obstructive Pulmonary Disease', 'Chronic Bronchitis', 'Emphysema', 'Airflow Obstruction, Chronic', 'Chronic Airflow Obstruction', 'Chronic Obstructive Airway Disease', 'Chronic Obstructive Lung Disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '28340861', 'type': 'DERIVED', 'citation': "D'Urzo A, Rennard S, Kerwin E, Donohue JF, Lei A, Molins E, Leselbaum A. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017 Apr;125:39-48. doi: 10.1016/j.rmed.2017.02.008. Epub 2017 Feb 16."}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4062&filename=lac-md-36-synopsis.pdf', 'label': 'lac-md-36-synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of the treatment phase of the lead-in study, LAC-MD-31\n* Written informed consent obtained from the patient before the initiation of any study specific procedures\n* No medical contraindication as judged by the PI\n* Compliance with LAC-MD-31 study procedures and IP dosing.\n\nExclusion Criteria:\n\n* No specific exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01572792', 'briefTitle': 'Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'LAC-MD-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose', 'interventionNames': ['Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose', 'interventionNames': ['Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Aclidinium bromide 400 μg', 'interventionNames': ['Drug: Aclidinium bromide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Formoterol Fumarate 12 μg', 'interventionNames': ['Drug: Formoterol Fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)', 'type': 'DRUG', 'description': 'Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day', 'armGroupLabels': ['1']}, {'name': 'Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)', 'type': 'DRUG', 'description': 'Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day', 'armGroupLabels': ['2']}, {'name': 'Aclidinium bromide', 'type': 'DRUG', 'description': 'Inhaled Aclidinium bromide 400 μg, twice per day', 'armGroupLabels': ['3']}, {'name': 'Formoterol Fumarate', 'type': 'DRUG', 'description': 'Inhaled Formoterol Fumarate 12 μg, twice per day', 'armGroupLabels': ['4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inhaled dose-matched placebo, twice per day', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1827', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1920', 'geoPoint': {'lat': 34.80243, 'lon': -86.97219}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1162', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1493', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1937', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36542', 'city': 'Gulf Shores', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1824', 'geoPoint': {'lat': 30.24604, 'lon': -87.70082}}, {'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 2088', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '35768', 'city': 'Scottsboro', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 1918', 'geoPoint': {'lat': 34.67231, 'lon': -86.03415}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 0909', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 1379', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1822', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1483', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '93726', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1156', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1871', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1873', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 2064', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1427', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95842', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1866', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1125', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 2009', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1374', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1813', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 1883', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 1380', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '81001', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 1137', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Forest Investigative Site 1327', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Forest Investigative Site 1976', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33744', 'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1821', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1154', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1944', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1364', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1152', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1875', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '70433', 'city': 'Covington', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1811', 'geoPoint': {'lat': 30.26854, 'lon': -83.83071}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 0670', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32132', 'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1516', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 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'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1167', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1432', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34119', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1819', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '33179', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1808', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '34677', 'city': 'Oldsmar', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1950', 'geoPoint': {'lat': 28.03418, 'lon': -82.6651}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1145', 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